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The PREVENA RESTOR(TM) Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.

The negative pressure technology for the subject device is the same as that for the predicate device systems. The PREVENA RESTOR™ dressing is a component of the PREVENA RESTOR™ Incision Management System. The systems provide surgical incision management via the application of negative pressure wound therapy over an incision site that has been closed with sutures or staples. The systems are applied to the incision site immediately after surgery for up to seven (7) days depending on the surgeon's preference. The pump in the therapy unit delivers continuous negative pressure at -125 mmHg through tubing connected to a PREVENA RESTOR™ dressing placed over the incision site. The integrated one-piece dressing, which includes an occlusive film, provides a negative pressure environment and protects the incision from external contamination. The application of negative pressure draws the incision edges together and removes fluid from the incision site into a canister fitted to the therapy unit.

The provided text is a 510(k) summary for the PREVENA RESTOR™ Incision Management System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through clinical studies typical of novel algorithms.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an FDA 510(k) clearance for this device is not applicable in the way it might be for a new AI/ML-based diagnostic device requiring performance against clinical endpoints.

Instead, the submission relies on demonstrating that the new device (PREVENA RESTOR™) is substantially equivalent to previously cleared predicate devices (K180855, K161897, K153199) by comparing technological characteristics and showing that a specific performance aspect (delivery of continuous negative pressure) is equivalent.

Here's a breakdown of the relevant information provided, with explanations for why some requested elements are not present:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: For this 510(k) submission, the "acceptance criteria" were demonstrating substantial equivalence to predicate devices in areas such as design, materials, principles of operation, mode-of-action, safety, performance, type of packaging, and indications for use.
• Reported Device Performance:
  • Performance Claim: The PREVENA RESTOR™ Incision Management System is substantially equivalent to the predicate in the delivery of continuous negative pressure at -125 mmHg within specifications under worst-case conditions of air leak rate and fluid input over the intended duration of use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable in this context. The "test set" here refers to bench testing performed on the device itself, not a clinical data set or a dataset for an AI algorithm. The text describes "bench testing" to demonstrate performance, but does not specify sample sizes or data provenance for this engineering testing. It falls under "non-clinical tests."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. This device is a negative pressure wound therapy system, not a diagnostic AI/ML algorithm requiring expert ground truth for interpretation of medical images or other diagnostic data. The "ground truth" for its performance is its ability to mechanically deliver negative pressure as specified, which is evaluated through engineering bench tests, not expert review.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. As explained above, this is not a study assessing diagnostic performance where adjudication methods for ground truth would be relevant.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is not an AI-assisted diagnostic device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance would have been performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a medical device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable in the traditional sense of diagnostic devices. For this mechanical device, the "ground truth" for its function is its ability to maintain a specified negative pressure. This is determined by engineering measurements against known physical standards and specifications during bench testing.

8. The sample size for the training set

• Not Applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

9. How the ground truth for the training set was established

• Not Applicable. As there is no training set, there is no ground truth to establish for it.

Summary regarding the study:

The study referenced is "Bench testing" which demonstrated substantial equivalence to predicate devices. This bench testing focused on the device's ability to maintain continuous negative pressure at -125 mmHg within specifications under various conditions (worst-case air leak rate and fluid input) over its intended duration of use. The 510(k) states that "No clinical tests were necessary" and "No usability testing was required as there has been only minor changes to the user interface and to the Instructions for Use." This indicates that the regulatory pathway for this particular device relied entirely on non-clinical (bench) testing to demonstrate substantial equivalence, rather than extensive clinical trials or performance studies against defined clinical endpoints.

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